# Investigating polypharmacy-related adverse events in critically ill children using electronic health records and simulated drug levels

> **NIH NIH K23** · DUKE UNIVERSITY · 2020 · $146,692

## Abstract

Polypharmacy is common in critically ill children and causes adverse events, including death. Identifying and
understanding how specific drug combinations contribute to adverse events is challenging in critically ill
children, requiring knowledge of drug levels and their relationships to adverse events. Although such
information could be obtained from clinical trials, the execution of these trials for every drug combination is
virtually impossible. Dr. Zimmerman aims to develop and evaluate an approach that combines electronic health
records and simulated drug levels to identify and characterize polypharmacy-related adverse events in critically
ill children. She hypothesizes that the combined approach will describe a relationship between drug levels and
a specific adverse event similar to that identified through a clinical trial. This approach could then be used as a
platform for evaluating safety in drug combinations frequently used in children. Dr. Zimmerman will conduct a
pilot clinical trial to evaluate relationships between delirium scores and drug levels of fentanyl and
dexmedetomidine in mechanically-ventilated children. She will then identify a single-center cohort from Duke
electronic health records and apply PK models to predict drug levels in this population. Using advanced
pharmacoepidemiologic methods, she will create statistical models to describe relationships between
simulated drug levels and delirium scores. She will compare results to those obtained in the clinical trial.
Finally, she will evaluate the broader applicability of the combined approach in a multicenter electronic health
record cohort. Dr. Zimmerman is a pediatric intensivist with a proven commitment to patient-oriented research
and a desire to acquire sophisticated skills in pharmacoepidemiologic methods. The skills achieved as a result
of this proposal will facilitate the candidate's long-term career goal to advance public health by developing new
methods to leverage information from large databases to increase the safety of drugs administered to critically
ill children. The candidate's short-term career goals for the K23 program are to: 1) acquire knowledge and
skills in optimal clinical trial design and pharmacoepidemiology; 2) develop the professional skills to
successfully lead a clinical trial research team; and 3) produce preliminary data and publications to support an
R01 grant application and establish a program of independent research in pediatric pharmacoepidemiology.
This proposal will capitalize on unique opportunities provided by the Duke Clinical Research Institute (Smith,
mentor) and the UNC epidemiology PhD program (Stürmer, PhD advisor). The mentorship team assembled is
uniquely qualified, and strengths include extensive clinical research experience, internationally recognized
thought leadership in trial design, clinical pharmacology, and pharmacoepidemiology; and a successful history
of mentorship of junior faculty. At the conclusion of this progr...

## Key facts

- **NIH application ID:** 9994761
- **Project number:** 5K23HD091398-04
- **Recipient organization:** DUKE UNIVERSITY
- **Principal Investigator:** Kanecia Obie Zimmerman
- **Activity code:** K23 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $146,692
- **Award type:** 5
- **Project period:** 2017-09-13 → 2021-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9994761

## Citation

> US National Institutes of Health, RePORTER application 9994761, Investigating polypharmacy-related adverse events in critically ill children using electronic health records and simulated drug levels (5K23HD091398-04). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/9994761. Licensed CC0.

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